Stem cells could be described as cells which have not yet chosen a "career
path"; and have the potential to become many different types of cell. There are
several types of stem cells, some found in the bone marrow are already committed
to the "career path" of immune cells but have not differentiated into specific
types of immune cell. Others have the potential to become almost any cell in the
body (such as cells in early embryonic tissue).Some stem cells have already
been used in medicine for many years. Bone marrow transplants are a
long-standing and safe treatment for children with leukaemias and deficient
immune systems. They work by seeding the body of the recipient with stem cells
which multiply and become the immune cells that the child needs to fight
Stem cells also offer the hope of a cure for many types of disease,such
as insulin-dependant diabetes, Parkinsons disease and tissue damage such as that
suffered by spinal trauma victims. Charitable organisations have expressed their
support for stem cell research which, they consider, will be of great benefit to
the patients they represent.
For more information about some these organisations, click on the following
Stem cell lines are stem cells that have been isolated from tissue or blood
and held in liquid culture medium under conditions designed to support their
growth and proliferation. Under the correct conditions this proliferation
enables substantial expansion of the cell numbers.
Following expansion, the stem cell cultures can be harvested, divided into
vials and preserved at ultra-low temperatures. This stock of frozen cells is
called a cell bank and the freezing process is a crucial stage which enables the
cell bank to be stored in a viable and stable state until required. The cells
can be thawed and re-cultured for research or therapy. Holding the cells in
suspended animation this way also enables extensive quality control and safety
testing to be performed before the cells are approved for use.
In some cases, such as embryonic stem cells the cultures appear to have the
capacity to expand indefinitely, without changing. Such cell cultures are called
stem cell lines.
The bank exists to establish and make available fully characterised and
quality-controlled cell banks. These will be supplied to scientific research
teams and eventually to pharmaceutical companies, to enable the development of
broad-ranging cell therapies. The bank will support the development of stem cell
therapy in the UK by:
The UKSCB and its local management committee will:
The National Institute for Biological Standards and Control (NIBSC) is proud
to have been selected as the host for the UK Stem Cell Bank. NIBSC is a
publicly-funded scientific organisation whose function is to assure the quality
and safety of biological medicines (mainly vaccines and blood products).
Every batch of vaccines used in the childrens vaccination programme in the UK
has been tested and approved by NIBSC. All blood-derived products used in the UK
are tested at NIBSC for freedom from contaminating viruses such as hepatitis and
Through its research and development activities it has built up an
international reputation, over many years, for its work on the safety and
quality of biological medicines such as vaccines and blood products. It also has
direct experience of developing and archiving cell lines for clinical
applications. Notably, NIBSC established and distributes the MRC-5 cell line
that is now in routine use around the world for the production of adult and
childhood vaccines. It is therefore a natural development for the Institute to
take on the role of establishing and running the UK Stem Cell Bank, and helping
to ensure as far as possible that stem cell therapy is developed in an
appropriate framework of quality and safety.
NIBSC has a long and distinguished history in the regulation of biological
medicines. In the early 20th century UK scientists realised that the strength of
certain medicines could only be assayed in relation to a preparation of known
strength. One of these medicines was insulin and in the 1920s the very first
standard reference material for the assay of insulin was made in the UK. Since
then NIBSC has been required to expand the range of products it works on and now
occupies a large and developing set of purpose-built labs in Hertfordshire.
In addition NIBSC has long experience in areas of direct relevance to the UK
Stem Cell Bank, including the standardisation of cytokines and growth factors.
Further standardisation activities relevant to stem cell therapy, include the
preparation qualified cell banks and providing an open forum for discussion of
quality and safety issues within the organ and bone marrow transplant
communities in the UK health service.
NIBSC has a history of successful customer-focused supply of materials to the
research community. In addition to its role in ensuring the safety and efficacy
of products NIBSC operates as an International repository for several classes of
The Centralised Facility for AIDS Reagents supplies research materials to
scientists working on HIV research.
International Biological Standards are the Gold Standards for testing the
strength of almost all biological materials and are held at NIBSC and
distributed to companies, public health authorities, WHO laboratory networks and
Working reagents for use by the UK transplantation laboratories are being
developed and supplied by NIBSC, in collaboration with these laboratories.
Application to deposit a stem cell line in the UK Stem Cell Bank must be made
to the Steering Committee for the Bank. Application forms are available on this
website and via the link to the MRC website.
The completed application forms together with supporting documentation should
be sent to the Medical Research Council who act as the secretariat for the
NB. The UKSCB system provides protection for depositor intellectual property
through a set of three agreements.
Queries regarding availability of stem cell lines may be made directly to the
UK Stem Cell Bank or by consulting the relevant page on this website. Requests
for permission to obtain stem cell lines must be made to the Steering Committee
for the UK Stem Cell Bank on the application form available on this website or
from the MRC website via the links page.
The Bank is currently funded via a grant from the MRC and BBSRC which is
intended to fund the construction and running costs of the Bank over a 3 year
period. The charging regime for stem cells is under review by the funding
councils and the Bank. The Code of Practice for the Bank, developed by the
Steering Committee, requires that the Bank recover marginal costs from academic
users and full costs from commercial users. The purpose of the Bank is to
promote research and the development of therapeutic applications. Any charging
regime for the Bank approved by the sponsors will reflect this commitment.
Under its Code of Practice, the Bank is prohibited from conducting research
that might be seen to produce a conflict of interest between the distribution of
stem cell lines and the free dissemination of information available on them.
This includes a prohibition on discovery research such as research on
fundamental stem cell biology and that which might result in commercial
application. The Bank is encouraged to undertake research approved by the
Steering Committee on the characterisation of stem cells, on quality and safety
issues and on improvements to current processing and storage protocols.
Any intellectual property arising out of the Bank’s approved research rests
with the MRC during the initial funding phase. Other than this, the Bank will
not take any interest in intellectual property embodied in depositing cell lines
or become involved in IP negotiations between depositors and users.
A pre-requisite for depositing in the UK Stem Cell Bank is that the owner of
the stem cell line signs a Materials Deposition Agreement (MDA) with the Bank
agreeing to make the stem cell line available to requestors for research
purposes, on terms of access to be negotiated between the depositor and any
future requestor in the Materials Use Licence (MUL).
A pre-requisite for approval to access banked stem cell lines is a MUL
negotiated between the requestor and the depositor setting out the rights of
expectation and ownership of any intellectual property arising out of the
research conducted by the requestor. A successful application to the Steering
Committee to access stem cell lines will then require the completion of a
Materials Access Agreement (MAA) between the Bank and the requestor before cell
lines are released. A specimen MAA and guidance on MULs is provided in the
annexes that accompany the Code of Practice for the UK Stem Cell Bank available
on the MRC website.
The UKSCB provides cells to all named partners in projects approved by the
Steering Committee. These partners may include academic, government and
commercial organisations. All partners will sign an agreement to receive the
cells and this will not permit transfer to other parties without
Any charging policy developed in accordance with the Code of Practice
for The Use of Stem Cell Lines (CoP) is advertised on the UKSCB
Charging for clinical grade hESC lines is acceptable under the CoP,
and charges levied by the UK Stem Cell Bank are described in section 6.6. as
The contract between the funders and the UK Stem Cell Bank makes provision
for a schedule of charges for the provision of stem cell lines to users. The
Steering Committee has indicated that the charges levied will be different for
academic researchers and commercial users of the Bank with commercial users
expected to pay the full economic costs. It is also expected that charging for
services provided by the UK Stem Cell Bank will be in line with general
principles applied by funding bodies and will allow for recovery of some of the
operating costs of the Bank over time. A schedule of charges has been
established by the Bank, but as of December 2009, no charges other than third
party shipping fees, have been levied for research grade cell lines. This
situation will be kept under review. An up to date schedule of charges
(including shipment charges) as well as notification of any change to the Bank’s
policy is available on the UK Stem Cell Bank website.